Helene L. N. Vu
Risk Management Plan Manager & Patient Safety Specialist at Novartis- Claim this Profile
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Norwegian Native or bilingual proficiency
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English Full professional proficiency
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Vietnamese Limited working proficiency
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Bio
Experience
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Risk Management Plan Manager & Patient Safety Specialist
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Jul 2021 - Present
Acting Deputy for local Country Patient Safety Head (CPSH), in case of unavailability and as Deputy for CPSHs within the Nordic Patient Safety (PS) group, in case of need and as agreed in advance, covering CPSH tasks including e.g. management of safety information, health authority requests, PS involvement in local programs and studies, audits and inspections, safety case compliance, Pharmacovigilance (PV) agreements, training and emergency response plan (ERP) as well as business continuity plan (BCP). Driving, managing and monitoring local implementation and compliance of global Risk Management Plan (RMP) commitments for Safety Risk Management Plans and local amendments to these plans as required. Providing input to global RMP Office as a member of the Global/Regional RMP Network. Local RMP manager deputy to other Nordic countries within Novartis. Support management of PS operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for PV of Novartis group, marketed and investigational products (drugs and devices). Support other Nordic countries with PV related tasks as applicable. Show less
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacovigilance and Medical Information Officer
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Dec 2019 - Jun 2021
Performing Pharmacovigilance (PV) activities in Sanofi Norway in accordance with local legislation and company guidelines. Handling Medical Information enquiries in Sanofi Norway in accordance with local legislation and company guidelines. Contribution to the overall success of Sanofi by establishing and sharing within the company a good knowledge of PV and Medical Information (MI), including legal and company requirements, and to contribute to the maintenance of good customer relations.Notable Contributions:• Handling of Individual Case Safety Reports and company QDs. • Providing relevant safety information to HA, internal stakeholders and external parties. Ensure involvement of the right representatives as appropriate.• Handling of Medical Information inquiries arising from Health Care Professionals, patients and other customers according to local legislation and company QDs.• Participate in writing and updating of local/MCO QDs according to corporate QDs and local legislation. Show less
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Country Safety Head (CSH) back-up
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May 2020 - May 2021
Be familiar with the overall structure of the affiliate PV and Medical Information systems in order to act during Country Safety Head (CSH) absence for the products of all Sanofi entities. Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training. Ensure that local PV activities are performed in compliance with the GPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in Norway and Iceland.Notable Contributions:• Implementation and development of local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country Medical Affairs, Country Regulatory Affairs and other appropriate functions.• Maintenance of the local PV System Master File in accordance with the global standards• Performed and ensure that education and training on PV and relevant safety topics within the local organization are performed including the documentation of attendees and topics covered. Show less
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Quality Officer and Responsible Person (RP) Deputy
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Feb 2019 - Dec 2019
Contribute in the management and maintenance of the Country Quality Document System. Provide support to the Country Quality Head (CQH) deputy in all product quality/technical matters and GXP related activities such as quality deviations, quality events, quality alerts and recalls of medicinal products from the market. Assure compliance with and implementation of EU GDP and local regulation (“Grossistforskriften”). Support and follow-up on Sanofi activities at Iceland related to quality systems. Execute operational tasks related to RP responsibilities as delegated by the Responsible Person (RP).Notable contributions:- Ensure management of Product Technical Complaints under the supervision of the Country Quality Head deputy .- Ensure maintenance of correct handling of temperature deviations of transportation or storage of Products.- Well managed batch commercialization process and release of Sanofi Pasteur vaccine to the Norwegian and Icelandic Market Show less
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Regulatory Affairs Officer
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Mar 2018 - Jan 2019
Supporting the submissions of marketing authorization applications and to maintain marketing authorizations through the life cycle management of Sanofi-Aventis’ products in Norway and Iceland. Timely updating of relevant databases, artwork approval, follow-up implementation deadlines for labelling, preparing and updating the national product catalogue “Felleskatalogen” in collaboration with Marketing and Medical functions.Notable contributions:- Ensuring optimal support to key stakeholders to ensure on-time delivery of high quality dossiers in compliance with Health Authority requirements.- Ensuring optimal expertise on all dossier formats, structure, navigation, and life cycle management globally- Ensuring close collaboration with Quality and Process Improvement team to ensure optimal processes and tools are developed and implemented- Compliance review in regards to 'Legemiddelindustriens (LMI) bransjeregler' Show less
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Vitusapotek
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Norway
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist
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Nov 2017 - Jun 2020
Vitusapotek CC Vest. Work of area contains cooperations with other health-based occupations, dispence medicine after prescriptions and guiding patiens regarding their medications. Notable Contributions: · Responsible for the pharmacy´s reimbursement settlement from the Norwegian Health Economics administration (HELFO) · Supported execution of current marketing strategies · Administrative task; Ordering. Secure suitable orders of RX-medicine, OTC- (Over the counter) and pharmaceuticals goods Show less
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Apotek 1
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Norway
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist
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Sep 2016 - Oct 2017
Pharmacy student licensed to work as a pharmacist at Apotek 1 Sfinxen. Work of area contains direct communication with other health-based occupations, accept prescriptions, dispence medicine and guiding patiens regarding their medications. Notable Contributions:· Contributor, deliverer and monitoring patients on Drug Assisted Rehabilitation (LAR)
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Pharmacist
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Jan 2016 - 2017
Pharmacy student licensed to work as a pharmacist at Apotek 1 Nordbyen. Work of area contains direct communication with other health-based occupations, accept prescriptions, dispence medicine and guiding patiens regarding their medications
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Pharmacy Technician
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Jun 2013 - Dec 2015
Pharmacy student working as a technician.
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Bohus AS
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Retail
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100 - 200 Employee
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Sales Associate
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Mar 2011 - May 2016
Bohus Larvik AS. Sales associate for the interior- and furniture department. Bohus Larvik AS. Sales associate for the interior- and furniture department.
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Education
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University of Oslo, Norway
Master's degree, Pharmacy